MAUDE Adverse Event Report: BIOTRONIK AG PASSEO-35 XEO 8/60/130; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	428874
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The passeo-35 xeo peripheral balloon catheter was selected for treatment of a mildly calcified lesion (80% stenosis degree) in a moderately tortuous part of the iliac artery.The device could not pass the lesion.Another balloon was used to finish the procedure.
Additional Manufacturer Narrative
The returned product was subjected to a detailed technical analysis and the corresponding production documentation was reviewed to establish whether a deviation from the manufacturing process could be the cause for the reported event.The technical investigation revealed that the device tip is severely deformed and has torn.The device tip shows indentations and chevron marks at its distal end.Microscopic inspection further revealed deformations of both the balloon and the proximal x-ray marker.The system profile and the distance between the x-ray markers do not comply anymore with the specification.This indicates that the device was forcefully pushed despite meeting resistance e.G.During device introduction which is, however, not related to the reported lesion crossing issue.Review of the production documentation verified that the device was manufactured according to specifications and successfully passed the in-process and final inspections.Based on the conducted investigations of the device being subject to this complaint, no material or manufacturing related root cause could be identified.The device tip was most likely damaged when attempting to push the device through the calcified lesion.However, it cannot be excluded that the device was manipulated after the reported event.
Event or Problem Description
The passeo-35 xeo peripheral balloon catheter was selected for treatment of a mildly calcified lesion (80% stenosis degree) in a moderately tortuous part of the iliac artery.The device could not pass the lesion.Another balloon was used to finish the procedure.

• Brand Name: PASSEO-35 XEO 8/60/130
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer (Section G): BIOTRONIK AG; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• Manufacturer Contact: ramona ergler ; ackerstrasse 6; bulach, zurich 8180 ; SZ 8180
• MDR Report Key: 23863037
• Report Number: 8043892-2025-12083
• Device Sequence Number: 21178755
• Product Code: LIT
• UDI-Device Identifier: 07640130452459
• UDI-Public: (01)07640130452459(17)280507(10)04253558
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K222065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 428874
• Device Lot Number: 04253558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown